In Practice/In Context™: HCV Updates and Insights

A 2019 In Practice/In Contextâ„¢ Publication

THE EPIDEMICS OF HIV, HCV, AND HIV/HCV COINFECTION IN THE CORRECTIONAL SETTING

ISSUE 2

HCV UPDATES and INSIGHTS

REALITIES, CHALLENGES, AND OPPORTUNITIES TO IMPROVE CARE Jointly provided by Global Education Group and Integritas Communications.

In collaboration with the

This activity is supported by an independent educational grant from Gilead Sciences, Inc.

National Hepatitis Corrections Network

UPDATES INSIGHTS HCV UPDATES and and INSIGHTS I HCV

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Contributors and Editorial Board Matthew Akiyama, MD, MSc (Editor in Chief) Assistant Professor of Medicine Department of Medicine Divisions of General Internal Medicine & Infectious Diseases Montefiore Medical Center Albert Einstein College of Medicine Bronx, New York Mandy Altman, MPA, CCHP Director, Correctional Health Program Hepatitis Education Project National Hepatitis Corrections Network Seattle, Washington Lara Strick, MD, MSc Clinical Associate Professor University of Washington Infectious Disease Physician Washington State Department of Corrections Tumwater, Washington Tracy Swan HIV and HCV Educator, Advocate, and Policy Advisor Brooklyn, New York Alysse G. Wurcel, MD, MS Assistant Professor, Tufts Medical Center Department of Medicine Division of Geographic Medicine and Infectious Diseases Tufts University School of Medicine Department of Public Health and Community Medicine Boston, Massachusetts

Target Audience

This activity has been designed to meet the educational needs of correctional health care professionals who treat incarcerated persons with or at risk for hepatitis C virus (HCV).

Educational Objectives

Upon completion of this activity, participants will be better able to »» Describe epidemiologic trends in HCV within correctional institutions »» Provide opt-out HCV testing in accordance with current guideline recommendations »» Demonstrate knowledge of corrections-based HCV treatment and prevention »» Identify challenges to effective HCV treatment and prevention within the correctional setting and at the time of community reentry

Program Description

We, in the correctional community, have a critical part to play in shaping health care delivery and advocating for our patients. This is especially pertinent to HCV care, in which significant gaps in testing, treatment, prevention, and education persist—both behind bars and upon community reentry. Across the corrections-based HCV-care continuum, providers are faced not only with challenges, but also with opportunities and options. This CorrectCare InPractice/InContext ™ HCV supplement is intended to provide highly relevant educational content, best-practice principles, and real-world perspectives for corrections-based HCV-care delivery and advocacy.

Disclosure of Conflicts of Interest

Global Education Group (Global) requires instructors, planners, managers, and other individuals and their spouses/life partners who are in a position to control the content of this activity to disclose any real or apparent conflict of interest they may have as related to the content of this activity. All identified conflicts of interest are thoroughly vetted by Global for fair balance, scientific objectivity of studies mentioned in the materials or used as the basis for content, and appropriateness of patient care recommendations.

The faculty reported the following financial relationships or relationships to products or devices they or their spouses/life partners have with commercial interests related to the content of this CME activity: Name of Faculty or Presenter Relationship Identified With: Matthew Akiyama, MD, MSc No financial relationships to disclose Mandy Altman, MPA, CHHP No financial relationships to disclose Lara Strick, MD, MSc No financial relationships to disclose Tracy Swan No financial relationships to disclose Alysse G. Wurcel, MD, MS No financial relationships to disclose The planners and managers reported the following financial relationships or relationships to products or devices they or their spouses/life partners have with commercial interests related to the content of this CME activity: Lindsay Borvansky Nothing to disclose Ashley Cann Nothing to disclose Andrea Funk Nothing to disclose Jim Kappler, PhD Nothing to disclose Ashley Marostica, RN, MSN Nothing to disclose Jeanette Ruby, MD Nothing to disclose

Physician Accreditation Statement

This activity has been planned and implemented in accordance with the accreditation requirements and policies of the Accreditation Council for Continuing Medical Education (ACCME) through the joint providership of Global Education Group (Global) and Integritas Communications. Global is accredited by the ACCME to provide continuing medical education for physicians.

Physician Credit Designation

Global Education Group designates this enduring activity for a maximum of 1.0 AMA PRA Category 1 Credit™. Physicians should claim only the credit commensurate with the extent of their participation in the activity.

Nursing Continuing Education

Global Education Group is accredited with distinction as a provider of continuing nursing education by the American Nurses Credentialing Center’s Commission on Accreditation.

This educational activity for 1.0 contact hour is provided by Global Education Group. Nurses should claim only the credit commensurate with the extent of their participation in the activity.

Fee Information

There is no fee for this educational activity.

Global Contact Information

For information about the accreditation of this program, please contact Global at 303-395-1782 or cme@globaleducationgroup.com.

Disclosure of Unlabeled Use

This educational activity may contain discussion of published and/or investigational uses of agents that are not indicated by the US Food and Drug Administration.

Global Education Group (Global) and Integritas Communications do not recommend the use of any agent outside of the labeled indications. The opinions expressed in the educational activity are those of the faculty and do not necessarily represent the views of any organization associated with this activity. Please refer to the official prescribing information for each product for discussion of approved indications, contraindications, and warnings.

Disclaimer

Participants have an implied responsibility to use the newly acquired information to enhance patient outcomes and their own professional development. The information presented in this activity is not meant to serve as a guideline for patient management. Any procedures, medications, or other courses of diagnosis or treatment discussed in this activity should not be used by clinicians without evaluation of patient conditions and possible contraindications on dangers in use, review of any applicable manufacturer’s product information, and comparison with recommendations of other authorities.

Release date: May 8, 2019 / Expiration date: May 8, 2020

INSTRUCTIONS TO RECEIVE CREDIT

After reading this supplement, please go to www.ExchangeCME.com/HCVCorrections to complete a short posttest.

In order to receive credit for this activity, the participant must pass the posttest with a score of at least 70% and complete the program evaluation.

CLINICAL RESOURCE CENTER

For more resources and references, please visit www.ExchangeCME.com/HCVCorrectionsResources

HCV UPDATES and INSIGHTS

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EDITORIAL AND SUPPLEMENT INTRODUCTION

A Wise Expenditure: HCV Testing and Treatment Within the Correctional Setting Matthew Akiyama, MD, MSc, Editor in Chief We are now well into the new era of hepatitis C virus (HCV) treatment with direct-acting antiviral (DAA) therapies. DAA treatment regimens are brief, well-tolerated, and associated with cure rates exceeding 95% if adherence is adequate.1 In order to achieve the World Health Organization’s (WHO) HCV elimination goals by 2030, it is imperative to scale up delivery of DAAs, particularly in high prevalence settings like prisons and jails.2,3

WHO 2030 HCV Elimination Goals

2

90%

DIAGNOSED of which

80%

TREATED

IN CONJUNCTION WITH HARM-REDUCTION MEASURES TO DRASTICALLY REDUCE NEW INFECTIONS

90%

Reduction in the New Chronic Infections

65%

Reduction in Mortality

many of whom are transitioning from prescription opioids to injection drugs.7 Whereas these younger individuals may have little to no liver fibrosis, they are at greater risk of HCV transmission, especially as they cycle between corrections and their communities.

Although successful HCV treatment, or sustained virologic response, is lasting and curative, it is critical to develop an infrastructure that gets treatment to the patients who need it. The HCV-treatment infrastructure needs to accommodate corrections-based clinicians, educators, and other essential treatment-team members who initiate and manage care. Developing a comprehensive model for HCV treatment scaleup is undeniably challenging given the high volume of HCV cases in corrections. However, other chronic diseases—including HIV—can provide models for how to overcome some of these challenges.

Despite the difficulties, we must persist in our efforts to both provide and scale up HCV care in corrections. Access to HCV evaluation and treatment during confinement goes beyond the mandated legal provision of care.8 By treating people living with HCV in correctional settings we stand to improve population-based outcomes by preventing onward HCV transmission in communities where people living with HCV return.

Due to the intersection of HCV, substance use disorders, and the criminal justice system, HCV prevalence in the correctional setting is far higher than in the surrounding community. However, precise prevalence estimates are difficult to pinpoint because of the lack of consistent testing strategies and routine confirmatory testing. Despite the variety of testing strategies implemented—from risk-based to birth-cohort (ie, baby boomer) to universal screening—the same conclusion emerges: universal opt-out screening is the optimal strategy for case finding in prisons and jails. The Federal Bureau of Prisons has recommended this strategy since 2016, yet implementation has been inconsistent in state and county correctional systems.4 Based on available data, HCV prevalence in corrections is estimated to be approximately 10–20 times higher than in the community setting.5

Historically, the cost of DAA therapies was undeniably a major barrier to attainment of higher HCV treatment rates. With these medications generally paid for through either state or county budgets, a “perfect storm” arose: high costs plus high numbers of untreated persons with HCV in correctional settings. A variety of strategies have since been used to mitigate the prohibitive costs.9 Perhaps the most critical step toward affordability of DAA therapy has been the emergence of multiple treatment options, creating market competition and, thus, bringing prices down considerably. It is noteworthy, however, that even early in the DAA era, studies demonstrated the cost-effectiveness of screening and treating with DAA therapy in correctional settings, despite the high costs.10 Ongoing reductions in cost should promote further expansion of treatment.

The epidemiologic profile of people living with HCV in US correctional settings is changing. As in the surrounding community, there is a trend toward a bimodal age distribution.6 Older individuals with longer standing HCV have a greater probability of advanced fibrosis, cirrhosis, and hepatocellular carcinoma, but typically they have fewer current risk behaviors, and, therefore, have a lower risk of transmission.

Current injection drug users (IDU) are increasingly driving a demographic shift toward a younger, nonurban, HCV-infected population,

If we don’t treat HCV infection in correctional settings—whether primary infection, or the infrequent cases of reinfection—these individuals will live with ongoing viremia and remain at risk of transmission both during and after incarceration.

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HCV UPDATES and INSIGHTS

Benefits of HCV Cure The Individual and the Community

11−13

CURE Decreased Transmission

Improved Clinical Outcomes

Hepatic

Extrahepatic

Cirrhosis Decompensation Hepatocellular carcinoma Transplantation

QUICK FACTS ON HCV IN U.S. CORRECTIONS

Improved quality of life:

All-cause mortality Cardiovascular disease Malignancy Renal manifestations Diabetes Neurocognitive manifestations

This will lead to ongoing propagation of the HCV epidemic in the community, increasing the financial burden on Medicaid and state-funded health care systems.

Importantly, reducing the number of people living with HCV who return to the community also serves the interests of correctional facilities and systems. Fewer viremic individuals transmitting HCV to others within community networks of people at risk of incarceration means fewer cases of HCV entering or reentering jails and prisons—a bidirectional benefit, epidemiologically. Importantly, we must not lose sight of the individual patient. Treating individuals for HCV benefits their health and well-being.11–13 And that is central to our role as health care workers.

We can help people who have lived with HCV go back into the community knowing they’ve been cured. And we have the opportunity to say we contributed to that new start.

In developing this HCV Updates and Insights publication, it has once again been my privilege to collaborate with colleagues who are truly committed to elimination of HCV and HIV within corrections and the community.

of all persons with HCV

spend at least part of the year in corrections

~20% of ALL incarcerated persons are HCV antibody positive

MOST ARE UNAWARE OF THEIR HCV INFECTION

Alysse G. Wurcel, MD, MS, provides guidance on treatment of HIV/ HCV coinfection.

Lara Strick, MD, MSc, and Mandy Altman, MPA, CCHP, offer important insights into opportunities and options for provision of HCV-related services in corrections.

Tracy Swan and I, Matthew Akiyama, MD, MSc, discuss optimization of community reentry for persons with HCV or HIV/HCV coinfection.

90% eventually released

68%

reincarcerated within 3 years

We hope that this educational activity will ultimately benefit your patients and practices.

Durose MR, et al. Bureau of Justice Statistics (BJS). NCJ 244205. 2014. https://www.bjs.gov/content/pub/pdf/ rprts05p0510.pdf; Edlin BR, et al. Hepatology. 2015;62(5):1353-1363; Macalino GE, et al. Am J Public Health.

2004;94(7):1218-1223; Rich JD, et al. N Engl J Med. 2014;370(20):1871-1874; Spaulding AC, Thomas DL. JAMA. 2012;307(12):1259-1260; Varan AK, et al. Public Health Rep. 2014;129(2):187-195.

HCV UPDATES and INSIGHTS

The HIV/HCV Syndemic: More Than the Sum of the Parts

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Alysse G. Wurcel, MD, MS A syndemic occurs when two or more epidemics intersect and exacprogressive liver disease. However, the poorly tolerated and ineffective erbate the impact of each disease on vulnerable individuals and injectable interferon-based treatment—the only available treatment for populations. Human immunodeficiency virus (HIV) and hepatitis C HCV at the time—made many providers reluctant to refer PLWH for virus (HCV) are a prime example of this phenomenon. Despite being HCV treatment. As a result, end-stage liver disease was a leading cause quite different at the molecular level, these viruses share modes of of mortality among people living with HIV/HCV coinfection.11,12 1 transmission that facilitate a convergence of syndemic proportion. In the beginning of the HIV epidemic, it was estimated 13 that one third of people living with HIV (PLWH) in 2 the United States were coinfected with HCV. Early primary care guidelines for management of PLWH 1986 1998 2001 2002 2011 2013 Present recommended HCV testing at initial presentation >95 100 >90 for HIV care, and then as needed with ongoing risk 90 SVR12 = HCV Cure ~75 80 factors or liver test abnormalities.3 SVR Rate, %

Improved Cure Rates With Successive HCV Therapies

70

Over time, the HIV and HCV epidemics have evolved, 54-56 60 50 as have recommendations for testing. In 2005, surveil42 39 40 34 lance data from the Swiss HIV Cohort reported an 30 increasing incidence of HCV in HIV-positive men 16 20 6 who have sex with men (MSM), suggesting a demo10 0 graphic shift in the HCV epidemic.4 The proposed IFN IFN IFN/RBV IFN/RBV PEG PEG/RBV Pls 2nd Gen Pangenotypic 6 Months 12 Months 6 Months 12 Months 12 Months 12 Months BOC/TVR DAAs DAAs mechanisms underlying this apparent increase in Add-on IFN-free 8-12 Weeks BOC, boceprevir; DAA, direct-acting antiviral (drug); Gen, generation; IFN, interferon; PEG, pegylated interferon; Therapy 12 Weeks sexual transmission included simultaneous sexually PI, protease inhibitor; RBV, ribavirin; SVR, sustained virologic response; TVR, telaprevir. transmitted infections, unprotected anal sex, and comorbid substance use disorders.5 Guidelines shifted correspondingly, recommending annual HCV testing for all PLWH, Direct-acting antiviral (DAA) regimens for treatment of HCV have and more frequently as prompted by individual risk.6 At that time, been a total game changer for all people with HCV, especially for HCV prevalence increased nationally in parallel with the escalating people with HIV/HCV coinfection. The COSMOS study, presented opioid epidemic, significantly impacting younger, predominately white, at the American Association for the Study of Liver Diseases (AASLD) 7 nonurban populations. Nationally, sexual transmission remains the annual meeting in 2013, was the first to demonstrate that an all-oral predominate route for HIV acquisition, but there have been several regimen with 3 medications (simeprevir, sofosbuvir, and ribavirin) outbreaks of HIV in people who inject drugs (PWID.)8 In the Scott effectively eradicated HCV virus in >90% of patients.14 This study County, Indiana, outbreak (2014–2015)—an often-cited epidemiologic employed a monitoring parameter indicating sustained virologic case in point—over 90% of individuals with newly diagnosed HIV also response (ie, undetectable HCV viral load) at 12 weeks after completion had HCV infection.9 The take-home point: HIV and HCV are interof HCV treatment (SVR12). The use of SVR12 as an operationaltwined epidemics—if one of these infections is present, the other should ized parameter has since extended from the research world to clinical automatically be considered in tandem. practice, and is now the universal definition of viral clearance and, in clinical terms, the definition of HCV cure.

Treatment of HCV in PLWH should be prioritized (please see other triage considerations, page 7). PLWH are less likely to spontaneously clear the hepatitis C virus because of their diminished immune responses. Further, HIV coinfection accelerates HCV-related liver damage, as demonstrated by a 2013 study in which persons coinfected with HIV and HCV had liver fibrosis measurements equal to those of HCV-monoinfected persons who were nearly one decade older.10 Therefore, identification of HCV in PLWH was essential and remains so, for proactive counseling, monitoring, and management of

Since the approval of the first all-oral HCV therapies, DAA regimens have progressively become more efficacious, shorter in treatment duration, better tolerated, and easier to manage. And, although minor modifications are needed in the presence of more advanced liver disease, most treatment courses remain at 8–12 weeks in duration. As recently as 2017, knowing the patient’s HCV genotype (genotypes 1–6) was necessary for choosing the most efficacious HCV treatment.

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FDA-Approved First-line DAA Regimens HCV Monoinfection and HCV in HIV/HCV Coinfection

Drug Regimen

Indications for Treatment-Naive Adults With or 15,16 Without Compensated Cirrhosis

Duration of Treatment

EBR/GZR

Patients with genotype (GT)1 or GT4 chronic HCV infection

12 weeks

GLE/PIB

Patients with GT1–GT6 chronic HCV infection without cirrhosis

 8–12 weeks

LDV/SOF

Patients with GT1, 4, 5, 6 chronic HCV infection without cirrhosis

12 weeks

SOF/VEL

Patients with GT1–GT6 chronic HCV infection without cirrhosis

12 weeks

Pangenotypic

Pangenotypic

or with compensated cirrhosis

or with compensated cirrhosis

or with compensated cirrhosis

Now, there are 2 FDA-approved pangenotypic regimens: sofosbuvir/ velpatasvir (SOF/VEL) and glecaprevir/pibrentasvir (GLE/PIB)— further enhancing efficacy, as well as ease of regimen selection. Other approved first-line regimens include elbasvir/grazoprevir (EBR/GZR) and ledipasvir/sofosbuvir (LDV/SOF).15,16 Unlike prior interferon-based therapy, DAAs do not rely on the immune system, since they directly act on the HCV virus. Therefore, these therapeutic advances have shifted the HIV/HCV–coinfection treatment paradigm from watchful waiting to proactive engagement in curative HCV treatment.17

Now, treatment of HCV in patients with HIV coinfection is no different from treatment for HCV monoinfection.15,16 And, although some drug-drug interactions between HIV and HCV medications must be considered, most first-line HIV antiretroviral (ARV) regimens do not interact with first-line, pangenotypic HCV regimens (GLE/PIB and SOF/VEL), making treatment monitoring much easier. Several online resources, including the AASLD/Infectious Diseases Society of America (IDSA) HCV Guidance publication and the University of Liverpool HCV drug interactions website are helpful when there are concerns regarding potential adverse interactions.15,18

Moreover, despite lingering concern that concurrent use of protease inhibitors, tenofovir disoproxil fumarate (TDF), and HCV medications should be avoided because of potential renal toxicity, these combinations have now proven to be safe.18 Nonetheless, special attention does need to be paid when an individual is on the ARV efavirenz or requires less commonly used ARVs, such as etravirine, due to HIV viral resistance, as these HIV medications may interact with HCV medications.18,19 Yet, while dialysis-dependent individuals with HIV/ HCV coinfection were once considered the most difficult to treat, this has not been a concern since approval of DAA medications that are not renally cleared.20 Many clinicians also have remaining concerns regarding HCV treatment in people with HIV/HCV coinfection who continue to engage in high-risk behaviors, prompting hesitancy on the part of these providers to offer DAA therapy. However, recent or active drug use, or unprotected high-risk sexual activity, should not be barriers to HCV treatment.

There is now ample real-world evidence of the feasibility and efficacy of treating HCV in PWID, whether as HCV monoinfection, or in the context of HIV coinfection.21

HCV UPDATES and INSIGHTS HIV-infected PWID have high rates of HIV medication adherence and viral suppression.22 At the patient level, this is a positive indicator that the individual will have good HCV-treatment adherence and achieve viral clearance. Across the scope of concerns, the realities of baseline drug use, ongoing injection drug use during DAA therapy, concurrent medication-assisted treatment (MAT) for opioid use disorder, and HIV/HCV coinfection itself are counterbalanced by evidence of HCV-treatment outcomes comparable to those in non-PWID. Composite studies show 93% to 95% SVR12 among PWID with recent or ongoing injection drug use; near-identical SVR12 achieved in MAT vs non-MAT PWID; no drug-drug interactions with MAT; and no negative impact of HIV/HCV coinfection Baseline drug use on SVR12.21 Further, Continued injection drug use clearance of HCV leads during DAA therapy to fewer liver-related Concurrent medication-assisted complications—cirrhotreatment for opioid dependence sis and hepatocellular HIV/HCV coinfection carcinoma—in people 23 with HIV. For a complete list of references associated with this figure, please

The next frontier in HCV clinical research is determining how early in the disease continuum treatment can be introduced, and how short a course of therapy can achieve viral clearance. Currently, HCV treatment is not recommended in acute stages. However, a Dutch study (DAHHS2; 2018) of 80 MSM with HCV infection of <6 months duration (including 24% [19/80] reinfections), 91% of whom had HIV coinfection, demonstrated an SVR12 rate of 94% to 98% following an 8-week course of EBR/GZR.26 21

93%−95% SVR12 among PWID with recent or ongoing injection drug use Near-identical SVR12 rates achieved in MAT vs non-MAT PWID No drug-drug interactions with MAT No negative impact of HIV/HCV coinfection on SVR

visit www.exchangeCME.com/HCVCorrectionsResources.

With or without HIV coinfection, post-cure HCV reinfection can occur when persons continue to engage in risk behaviors. Yet, from a public health point of view, providing primary HCV treatment for these individuals even if there is high risk of post-cure HCV reinfection—and treating reinfection when it occurs—decreases community viral load (prevalence) and moves us closer to HCV elimination. This approach is most effective when coupled with promotion of harm reduction services, such as syringe services programs and MAT, within local PWID populations, thereby decreasing new HCV cases and reinfections (incidence). Colocation of

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HCV care and harm-reduction services may provide the greatest population-based benefits.24,25

Real-World Evidence

REALITIES

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Thus, as further support for the efficacy, tolerability, and feasibility of treatment in the acute phase accrues, and the costs of DAA therapies continue to decrease, treatment of acute HCV may be recommended. Similarly, the use of DAAs as HCV preexposure prophylaxis has not been approved, but there may be an even-

tual role for such use as the costs come down.27 If the ultimate population-based outcome is HCV elimination, we in the United States still have a long road ahead. Nowhere is the need to address HCV greater and the logistics for doing so more complex than in the correctional setting. Treatment as prevention—treating all people with HCV regardless of risk behaviors, HIV coinfection, or reinfection post cure—is the only route to attain that goal.

SPOTLIGHT ON SUCCESS

Hepatitis Education Project, Washington State A UNIQUE COMMUNITY-BASED PRISON REENTRY PROGRAM

Hepatitis Education Project (HEP), a Seattle-based nonprofit organization, addresses the challenges faced by individuals with HCV at the time of their release from Washington state prisons. HEP encourages incarcerated patients to contact its office during release planning or immediately after release for help navigating community-based HCV treatment.

Patients work with a HEP case manager who specializes in comprehensive services: »» Finding secure housing »» Obtaining medical records and arranging for an appropriate HCV-treatment provider »» Providing referrals for behavioral health needs, medication-assisted treatment, and syringe services »» Assisting with employment search, transportation needs, and obtaining a mobile phone

FOR MORE INFORMATION: Mandy Altman, MPA, CCHP mandy@hepeducation.org

EDUCATION RESOURCES SUPPORT ADVOCACY

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HCV in the Correctional Setting:

Opportunities and Options Along the Care Continuum Mandy Altman, MPA, CCHP Lara Strick, MD, MSc Joining the efforts toward hepatitis C virus (HCV) elimination goes beyond providing direct-acting antiviral (DAA) treatment.

Correctional health care providers and administrators have multiple opportunities and options when considering implementa-

tion of HCV prevention and care in their facilities. This comprehensive HCV care continuum includes education, screening, and harm reduction in addition to treatment. Both jails and prisons can have a tremendous impact on the HCV epidemic, sometimes with even minor changes to existing processes. Not surprisingly, barriers

to setting up any sort of program within corrections frequently involve the start-up efforts and the costs. Having an inside HCV champion, a corrections professional who can garner the institutional leadership’s buy-in for improving the HCV care continuum, is often the key to successfully overcoming implementation barriers.

The HCV Care Continuum for the Corrections Setting: Opportunities for Action HCV-WORKFORCE EXPANSION

EDUCATION TACTICS

Encourage and train PCPs

Develop education: in-person, video, or peer-directed

Expand telehealth and video conferencing

Incorporate harm reduction into prevention programs

Expand access to specialists

Garner support for prevention

SCREENING AND DIAGNOSIS

Provide universal opt-out testing

Develop realistic estimation of HCV burden

HCV Prevention and Harm Reduction TRIAGE AND STAGING

TREATMENT

Triage strategies: Risk of transmission vs disease severity

DAA selection

Staging modalities: Adapt case by case

Retreatment

Avoid staging bottleneck

Timing and venue considerations

COMMUNITY REENTRY

Proactive treatment planning: provide linkage to community-based services and HCV care Advocate for colocation of services

Initial & ongoing monitoring

ENSURING AN ADEQUATE HCV-TREATER WORKFORCE Although current DAAs are much easier to manage than HCV therapies in the interferon era, there is still significant hesitation on the part of many primary care providers (PCPs) to prescribe these highly effective medications. Therefore, limited availability of or access to HCV specialists can become a compounding barrier to HCV treatment. Yet,

with clear and concise HCV treatment guidelines, any PCP should be able to treat the majority of patients living with HCV. Specialist involvement in care may still be needed for patients with multiple treatment failures, significant comorbidities, or advanced liver disease. Such care can be provided directly by transporting patients out to the community; through telehealth, whereby outside providers actually “see” patients within the facilities; or, indirectly by means of an ECHO (Exten-

sion for Community Healthcare Outcomes) program in which PCPs are mentored by specialists via telemedicine media.1 Despite the ongoing need for specialists in certain clinical circumstances, it is crucial that PCPs become increasingly independent in treating HCV, thereby expanding the treatment workforce to accommodate larger numbers of patients.

HCV UPDATES and INSIGHTS EDUCATION Viral hepatitis education—including hepatitis A (HAV) and hepatitis B (HBV) and HCV— should be for everyone in a correctional setting, not limited to those who already have chronic HCV.2 Basic education and harm reduction counseling can be key to prevention within an entire correctional population.

Some facilities deliver basic viral hepatitis education in person, whether as a mandatory or optional activity. Alternatively, a video that includes how to access HCV services can be shown at intake as part of the standard orientation process. Voluntary participation by those who want to be engaged, followed by their sharing knowledge with others through peer-based education is often the most effective approach. The SHIELD program (SelfHelp in Eliminating Life-Threatening Diseases) provides a model for such programs.2 In the context of prevailing mistrust of the system, education from peers is sometimes more highly regarded than information coming from corrections staff. Peer educators should be chosen based on their social network and their social status, thereby enabling an effective reach to the broadest facility population possible. Adequate training of peer educators is critical for effective harm reduction education and counseling. Peers must have accurate knowledge, access to resources, and the ability to ask and respond to questions appropriately. Peer educators must also have good communication skills and be interpersonally engaging, abilities that can be enhanced by facility support and training. Yet administrative acceptance for prevention and harm reduction programs may be difficult to obtain. Presenting the merits of harm reduction from a cost perspective may be the key strategy.

If only one instance of HCV transmission—infection or reinfection—is prevented, that’s one less case to treat, and the harm reduction program has essentially paid for itself.

HIV/HBV/HCV

INJECTION RISK

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TRIAGE 2

Injecting using someone else's uncleaned needle and works Injecting using someone else's uncleaned cooker or works, but your own brand new needle Rinsing a used needle one time with cold water before injecting

Rinsing a used needle 5 times with cold water before injecting

Using a brand new needle and works every time you inject NOT INJECTING DRUGS

SCREENING AND DIAGNOSIS Screening and diagnosing HCV infection is the next component of the HCV care continuum. Ideally, testing (HCV-antibody screening followed by confirmatory HCV-RNA [ribonucleic acid] testing if antibody positive) is offered as part of an opt-out program at intake, as this has been shown to be the most effective way to identify persons living with HCV.3 Although the prevalence of chronic HCV is greatest among baby boomers (those born between 1945 and 1965), limiting testing to this age group in the corrections setting misses more than half of the cases.4,5 Even if an individual who tests positive for HCV RNA—indicating chronic infection—is not treated immediately, knowledge of an HCV diagnosis coupled with education empowers the patient, both in terms of self-advocacy and prevention of transmission to others.

A facility’s realistic estimation of its HCV burden may also inform the scale-up of HAV and HBV vaccination programs, even if that facility is not prepared to implement or expand HCV-related health care services.

The current American Association for the Study of Liver Diseases/Infectious Diseases Society of America (AASLD/IDSA) guidelines recommend treatment of all persons with chronic HCV.6 Logistically, fulfillment of this goal in correctional settings does not happen overnight. As a result, while facilities ramp up their HCV-treatment infrastructure and capacity, they must decide how to triage patients with HCV. On the one hand, the public health perspective provides a strong argument for targeting and treating those people who may have a higher potential for transmitting the virus to others.6,7 Typically, these are younger patients who have less advanced liver disease, fewer comorbidities, and a high likelihood of achieving sustained virologic response with a short duration of treatment (ie, 8−12 weeks). On the other hand, it is the clinical responsibility of the corrections facility to ensure access to HCV treatment for persons with the most advanced liver disease, given its more urgent and progressive nature.8 The management of these patients may be more complicated and require a longer duration of treatment (See Table: FDA-Approved First-line DAA Regimens, page 4.) Being able to provide treatment to all patients living with HCV and tackle the HCV epidemic ultimately will require community and public health partners to collaborate with their correctional colleagues.

STAGING With an eventual goal of HCV treatment for all infected persons, some clinicians question whether it will still be necessary to stage liver fibrosis (F0–F4) prior to treatment. It should be kept in mind that even in the absence of triage considerations, the liver fibrosis stage still informs regimen selection, postcure monitoring, and prognosis. There are simple noninvasive scoring tools (eg, aspartate aminotransferase to platelet ratio index [APRI] and fibrosis-4 index [FIB-4]; more complex algorithms for combined testing of serum-based biomarkers (eg, FibroSure®);

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imaging studies (eg, ultrasound, transient elastography, magnetic resonance elastography); and the more invasive, traditional reference standard, liver biopsy. No staging modality is consistently accurate, but in general, elastography or biopsy have greater sensitivity and specificity.9 Any staging protocol needs to be flexible and responsive to patients’ individual characteristics and, like the composite results of any clinical workup, staging parameters should be interpreted as a whole. When the data are discordant, further testing may be indicated. To address staging concerns as barriers to treatment access, some systems are buying their own mobile imaging equipment to eliminate staging as a bottleneck in the HCV care continuum. Some of these facilities have the novel goal of potentially scanning all patients who receive an HCV diagnosis at the time of intake, allowing correctional facilities to move toward a test-and-treat strategy for HCV.

TREATMENT SELECTION AND LOGISTICS Factors impacting the choice of a Food and Drug Administration–approved HCV-treatment regimen within correctional health care, in general, are similar to those factors considered in the community setting. The choice of regimen is usually based on specific patient and/or viral characteristics, as well as local and/or prevailing economic considerations.6 However, in correctional facilities, medication packaging and storage space may also influence the selection of DAA therapy.

For example, the thick plastic backing of some daily blister packs can be a safety concern, especially in higher custody environments.

This necessitates staff dispensing the medication via a pill line, or removing the plastic prior to dispensing. Other medications are provided in a single box for each day’s dose, enhancing both convenience and adherence in the community setting. This extra packaging, however, can take up considerable space in often cramped correctional-facility medication rooms. And package inserts often specify

that the drug must be dispensed in its original packaging, which precludes transferring it to a container that better suits the environment.

These practical considerations may impact treatment selection and logistics.

COMMUNITY REENTRY Transitions between the correctional setting and the community are times of risk for error or lapses in HCV treatment, whether treatment is initiated behind bars or on the outside. As treatment in the community is expanding, it is becoming increasingly important for jails to be able to continue DAA therapy when patients enter the facility during a course of HCV treatment. Conversely, anticipated length of incarceration and/ or remaining time until release may impact treatment initiation on the inside. It is not always feasible to ensure continuity of DAA therapy as patients transition to the community, often prompting deferral of treatment.

As HCV treatment in corrections expands, planned HCV treatment outside correctional facilities—after community reentry—may still be a reasonable alternative for some patients, particularly those with less advanced liver disease and very short sentences.

Adequate planning for HCV treatment after release increases the likelihood of a successful transition of care. For states with expanded Medicaid, it is possible to preenroll patients so that they can quickly and easily access treatment in the community.10,11 It is equally important to provide patients with education on how to navigate the medical system— or, even better—to preschedule the first community-based medical appointment for them. Giving patients copies of their medical records, or faxing copies, can also facilitate continuity of care and avoid duplicative services. Yet, eligibility for HCV treatment remains restricted in many states based on Medicaid criteria.12 Deferral of HCV treatment often makes patients who are subject to such restrictions feel like they are not worth being treated—that the “system” doesn’t care about them as individuals. This highlights

the importance of ensuring linkage to care by whatever means or logistics possible.

Being cured of HCV has significant psychological benefits for patients who have lived with the emotional burden of the disease and empowers many to make better life choices after being cured.

NEXT STEPS Ideally, facilities or systems should try to extract data and develop estimates of how many persons are screened for HCV, how many have positive confirmatory testing for chronic HCV, and how many are treated for HCV, and document corresponding longitudinal trends. Data are critical to any program evaluation; however, not all correctional facilities have electronic medical records in place and their reliance on paper-based systems can make data management and analysis very difficult. When available, these data can inform budgets for viral hepatitis education and HAV/HBV vaccination programs and, ultimately, impact HCV-treatment infrastructure and capacity.

These are just some of the first steps in assessing the opportunities and options for implementing or augmenting services along the HCV care continuum in your correctional setting. Pushing through attitudinal and systemic roadblocks may ultimately succeed on the basis of bottom-line cost savings and risk mitigation. If accomplished, this will enable corrections—the epicenter of the HCV epidemic—to play a major role in HCV elimination.

EXPERT INTERVIEW

HCV UPDATES and INSIGHTS

Optimizing Community Reentry for Persons with HCV or HIV/HCV Coinfection Matthew Akiyama, MD, MSc Tracy Swan, HIV and HCV Educator, Advocate, and Policy Advisor

QUESTION: What are some of the transition planning and reentry considerations specific to people with chronic hepatitis C virus (HCV)?

MA: In order to accommodate the large volume of people living with HCV in corrections

and transitioning to the community, a motivated health care workforce is essential. Health care leadership, clinicians, behavioral health specialists, and social service staff are needed to provide screening, confirmatory testing, HCV education, and when feasible, direct-acting antiviral (DAA) therapy. Support for linkage to community HCV care is critical to this continuum.

TS: For people who acquired HCV through injection drug use and are likely to use drugs when they leave corrections, it’s crucial to link them with a syringe service program.

Providing access to naloxone, which is an opioid antagonist that can reverse opioid overdose, is also crucial. People are vulnerable to overdosing when they reinitiate drug use. In 2017, 47,600 people in the United States died from opioid overdoses.1,2 If you approach HCV care and treatment holistically, taking other basic needs into account, you stand a better chance of engaging people in health care.

Some people have heard that DAA therapy is unaffordable or that access is restricted. It’s important to let people know that there are different pathways to getting HCV care and treatment. People at ongoing risk of HCV acquisition should be offered repeat testing, treatment, and retreatment, if necessary. Treating people who have been reinfected with HCV means you are reaching the right population of recent injectors.3

QUESTION: What are the key differences between transition planning for someone with HIV versus somebody with HCV? TS: If we assume that people living with HIV (PLWH) are on antiretroviral therapy (ART)

it’s critically important that there’s a way for them to seamlessly continue receiving it.

Initiating HCV treatment is important, but it is a less immediate need. But for people who have already started treatment, uninterrupted access is essential.

MA: We’re at very different stages of these two epidemics. Because of more robust resources and funding for PLWH, longer standing availability of ART, and more general, public knowledge of HIV, many PLWH already have some degree of contact with the health care system. Having established contact with a medical home, knowing how to navigate everything from the front desk onward, and having trust in a medical provider leads to higher and more sustained engagement in care among PLWH. For HCV, we’re at an earlier phase of the epidemic, where despite highly effective, well tolerated DAA therapies, there is still a lot of education that needs to be done surrounding HCV and DAA therapy in correctional settings. Additionally, patients living with HCV often need broad-based support during their transition to the community: from help linking to treatment for substance use disorders to assistance with housing and social services.

Without these additional services, there may be competing priorities that interfere with linkage to medical care.

Luckily HIV and HCV can often be treated by the same provider—typically either infectious disease specialists or primary care physicians who pursue additional HIV and/or HCV training.4 There has been long-standing funding for HIV transitional care programs, so there are more resources available to overcome barriers among individuals with HIV/ HCV coinfection. However, there are many situations in which patients are simply not able

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to access transitional care planning services because they have HCV monoinfection as opposed to HIV/HCV coinfection. This is a critical concern that we will really need to focus on to achieve HCV elimination.

QUESTION: For those individuals whose HCV treatment has been deferred until community reentry, where do you see the greatest barriers to linkage to care? Patients themselves; providers; systems?

MA: Knowledge of one’s HCV status will only motivate a certain subset of people to

connect to care—for example, those who may have fewer competing priorities and/or have existing engagement with a medical home prior to incarceration. Given that one of the major barriers associated with reentry is active substance use, which often cannot be overcome on one’s own, it is incumbent on correctional systems and providers to assist these individuals in linking to substance use treatment, as well as HCV care. This is well understood within the context of HIV, but now, to an even greater degree with HCV, since injection drug use is the number one risk factor for HCV. TS: The answer to your question is All of the above. There are barriers at every level and ways to nudge some of them aside. Patient-level barriers aren’t always medical—life circumstances need to be addressed when someone is transitioning to the community.

Peers can be extraordinarily helpful, since people who don’t interact often with the health care system may not be prepared to wait for hours and have only minutes to talk with someone who may use language that they don’t understand. This calls for both health care literacy and treatment literacy.5

QUESTION: What advice would you give correctional health care providers who wish to advocate for colocation of community-based services for those reentering the community?

TS: It’s a matter of ensuring that people are aware of community-based, colocated care as an option—when it’s available. And when it’s not available, peer navigation becomes even more important. Patient education on both the inside and outside is, therefore, a critical component of an overall advocacy strategy.

MA: Additionally, transitional care planning teams can be a hub of advocacy. These folks can be trained to know the landscape of the surrounding community in terms of what is and what is not available, and how to identify and set up services prior to release.6

QUESTION: Are there different transition planning considerations for HCV-infected persons in the baby boomer–birth cohort, versus the cohort of typically younger people who inject drugs?

TS: Mainly, I’d say if someone of the baby boomer–age cohort is newly diagnosed and is not currently engaging in risk behavior, they may have long-standing, and possibly advanced, liver disease. These patients need to be connected with care and treated sooner rather than later.

MA: Older patients with chronic HCV may share the challenges impacting younger patients who inject drugs, but there are some challenges that are distinct. For example, older patients often have medical comorbidities that take precedence over HCV, either from the patient perspective or clinically. These patients will likely require extra attention during transition planning because their comorbidities compound other challenges associated with linking to care. Conversely, younger people who are challenged by active substance use disorders may have less experience with the health care system.6 This younger group should be prioritized for treatment in order to reduce the risk of onward HCV transmission upon return to the community.

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QUESTION: How can the HCV care continuum most effectively be extended into the community for those who have been treated on the inside?

MA: These concerns can be broken into two broad categories. For those who are treated but remain at risk of reinfection due to ongoing substance use, we need to ensure that systems are robust to promote linkage to substance use disorder treatment. Coupling this with community-based providers’ awareness of ongoing HCV risk and the need to screen for reinfection is crucial.

For those with stage 3 or 4 liver fibrosis requiring ongoing monitoring for hepatocellular carcinoma, we should be aware of this reentry need at the provider level.7 Patients should also be adequately educated regarding their risk of progressive fibrosis, cirrhosis, and hepatocellular carcinoma since, ultimately, they can also be their own best advocates.

TS: Optimizing extension of the care continuum into the community is deceptively simple: It’s a matter of colocated services. Most people don’t like to run around and wait for hours in different locations. It’s nearly impossible to negotiate multiple medical

appointments, even with a case manager. Without one, it’s a full-time job. The easier we can make this for people, the more likely they are to be successful and have good health outcomes. Instead of a health care obstacle course, we can create more efficient and acceptable bundled services. There are a variety of ways to expand the colocated model, whether in an office-space setting, or even better, nonoffice syringe-exchange sites where you could offer and coordinate harm reduction, medication-assisted treatment for opioid use disorder, and HCV services.8 It’s also empowering for providers to feel they can deliver a range of coordinated services to people and watch them become healthier.

MA: The benefits of treating and curing HCV are multifold.9 Of course, the risk of progressive liver disease and extrahepatic manifestations are diminished, but beyond this, people feel less stigmatized and they often report feeling successful HCV treatment has provided a new start in life. To see this happen and be a part of it is very rewarding.

TS: I have talked with providers who are absolutely gleeful about being able to cure people. It must be amazing to have someone come in with what was once a very difficultto-treat, chronic viral infection and say “Guess what? You’re worth it. Your health is worth this investment.” That is really powerful.

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3. Spaulding AC, et al. HIV and HCV in U.S. prisons and jails: the correctional facility as a bellwether over time for the community’s infections. AIDS Rev. 2017;19(3):134-147.

4. Federal Bureau of Prisons. Evaluation and management of chronic hepatitis C virus (HCV) infection. https://www.bop.gov/resources/ pdfs/012018_hcv_infection.pdf. 2018.

5. Varan AK, et al. Hepatitis C seroprevalence among prison inmates since 2001: still high but declining. Public Health Rep. 2014;129(2):187-195.

6. Akiyama MJ, et al. Hepatitis C screening of the “birth cohort” (born 1945−1965) and younger inmates of New York City jails. Am J Public Health. 2016;106(7):1276-1277.

7. Centers for Disease Control and Prevention. Hepatitis C virus infection among adolescents and young adults—Massachusetts, 2002−2009. Am J Transplant. 2011;11(7):1535-1538.

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9. Akiyama MJ, et al. Drug purchasing strategies to treat people with hepatitis C in the criminal justice system. Am J Public Health.

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10. He T, et al. Prevention of hepatitis C by screening and treatment in U.S. prisons. Ann Intern Med. 2016;164(2):84-92.

11. Smith-Palmer J, et al. Achieving sustained virologic response in hepatitis C: a systematic review of the clinical, economic and quality of life benefits. BMC Infect Dis. 2015;15:19.

12. Negro F, et al. Extrahepatic morbidity and mortality of chronic hepatitis C. Gastroenterology. 2015;149(6):1345-1360.

13. George SL, et al. Clinical, virologic, histologic, and biochemical outcomes after successful HCV therapy: a 5-year follow-up of 150 patients. Hepatology. 2009;49(3):729-738.

The HIV/HCV Syndemic: More Than the Sum of the Parts 1. Perlman DC, Jordan AE. The syndemic of opioid misuse, overdose, HCV, and HIV: structural-level causes and interventions. Curr HIV/ AIDS Rep. 2018;15(2):96-112.

2. Sulkowski MS, et al. Hepatitis C virus infection as an opportunistic disease in persons infected with human immunodeficiency virus.

Clin Infect Dis. 2000;30(suppl 1):S77-S84.

3. Aberg JA, et al. Primary care guidelines for the management of persons infected with human immunodeficiency virus: recommendations of the HIV Medicine Association of the Infectious Diseases Society of America. Clin Infect Dis. 2004;39(5):609-629.

4. Rauch A, et al. Unsafe sex and increased incidence of hepatitis C virus infection among HIV-infected men who have sex with men: the Swiss HIV Cohort Study. Clin Infect Dis. 2005;41(3):395-402.

5. Danta M, et al. Recent epidemic of acute hepatitis C virus in HIV-positive men who have sex with men linked to high-risk sexual behaviours. AIDS. 2007;21(8):983-991.

6. Rockstroh JK, et al. European AIDS Clinical Society (EACS) guidelines for the clinical management and treatment of chronic hepatitis B and C coinfection in HIV-infected adults. HIV Med. 2008;9(2):82-88.

7. Suryaprasad AG, et al. Emerging epidemic of hepatitis C virus infections among young nonurban persons who inject drugs in the United States, 2006-2012. Clin Infect Dis. 2014;59(10):1411-1419.

8. Wejnert C, et al. Vital signs: trends in HIV diagnoses, risk behaviors, and prevention among persons who inject drugs — United States.

MMWR Morb Mortal Wkly Rep. 2016;65(47):1336-1342.

9. Peters PJ, et al. HIV infection linked to injection use of oxymorphone in Indiana, 2014–2015. N Engl J Med. 2016;375(3):229-239.

10. Kirk GD, et al. HIV, age, and the severity of hepatitis C virus–related liver disease: a cohort study. Ann Intern Med. 2013;158(9):658-666.

11. López-Diéguez M, et al. The natural history of liver cirrhosis in HIVhepatitis C virus-coinfected patients. AIDS. 2011;25(7):899-904.

12. Bica I, et al. Increasing mortality due to end-stage liver disease in patients with human immunodeficiency virus infection. Clin Infect Dis. 2001;32(3):492-497.

13. Image adapted from Strader DB, Seeff LB. A brief history of the treatment of viral hepatitis C. Clin Liver Dis. 2012;1(1):6-11.

14. Lawitz E, et al. Simeprevir plus sofosbuvir, with or without ribavirin, to treat chronic infection with hepatitis C virus genotype 1 in non-responders to pegylated interferon and ribavirin and treatment-naive patients: the COSMOS randomised study. Lancet.

2014;384(9956):1756-1765.

15. American Association for the Study of Liver Diseases/Infectious Diseases Society of America (AASLD/IDSA). HCV guidance: recommendations for testing, managing, and treating hepatitis C. https://www.hcvguidelines.org/. Last updated 2018.

16. US Food and Drug Administration. Drugs@FDA.org: FDA Approved Drug Products. https://www.accessdata.fda.gov/scripts/cder/daf/.

17. Bhattacharya D, et al. Effectiveness of all-oral antiviral regimens in 996 human immunodeficiency virus/hepatitis C virus genotype 1-coinfected patients treated in routine practice. Clin Infect Dis. 2017;64(12):1711-1720.

18. University of Liverpool. HEP drug interactions. www.hep-druginteractions.org. Last reviewed February 2019.

19. Khatri A, et al. Evaluation of drug-drug interactions between direct-acting anti-hepatitis C virus combination regimens and the HIV-1 antiretroviral agents raltegravir, tenofovir, emtricitabine, efavirenz, and rilpivirine. Antimicrob Agents Chemother. 2016; 60(5):2965-2971.

20. Ladino M, et al. Opportunities for treatment of the hepatitis C virus-infected patient with chronic kidney disease. World J Hepatol.

2017; 9(19):833-839.

21. Composite references for Real-World Evidence (Figure). See online Clinical Resource Center. www.ExchangeCME.com/ HCVCorrections.

22. Nolan S, et al. HIV-infected individuals who use alcohol and other drugs, and virologic suppression. AIDS Care. 2017;29(9):1129-1136.

23. Merchante N, et al. Sustained virological response to direct-acting antiviral regimens reduces the risk of hepatocellular carcinoma in HIV/HCV-coinfected patients with cirrhosis. J Antimicrob Chemother. 2018;73(9):2435-2443.

24. Grebely J, et al. Elimination of HCV as a public health concern among people who inject drugs by 2030 – What will it take to get there? J Int AIDS Soc. 2017;20(1):22146.

25. Martin NK, et al. Combination interventions to prevent HCV transmission among people who inject drugs: modeling the impact of antiviral treatment, needle and syringe programs, and opiate substitution therapy. Clin Infect Dis. 2013;57(suppl 2):S39-S45.

26. Boerekamps A, et al. Treatment of acute hepatitis C genotypes 1 and 4 with 8 weeks of grazoprevir plus elbasvir (DAHHS2): an open-label, multicentre, single-arm, phase 3b trial. Lancet Gastroenterol Hepatol. 2019. [Epub ahead of print] 27. Hepatitis C researchers eye pre-exposure prophylaxis. Hepmag. com. https://www.hepmag.com/article/hepatitis-c-researchers-eye-preexposure-prophylaxis. 2016.

HCV in the Correctional Setting: Opportunities and Options Along the Care Continuum 1. New Mexico School of Medicine. Project ECHO. https://echo.unm. edu/. Last updated January 2019.

2. Hepatitis Education Project. Correctional Health Program. http:// www.hepeducation.org/what-we-do/correctional-health-program.

2019.

3. American Association for the Study of Liver Disease/Infectious Diseases Society of America (AASLD/IDSA). HCV Testing and Treatment in Correctional Settings. https://www.hcvguidelines. org/unique-populations/correctional. Last updated May 2018.

4. Assoumou SA, et al. Hepatitis C testing and patient characteristics in Washington State’s prisons between 2012 and 2016. Am J Prev Med. 2019:56(1):8-16.

5. Kuncio DE, et al. Comparison of risk-based hepatitis C screening and the true seroprevalence in an urban prison system. J Urban Health. 2015;92(2):379-386.

6. AASLD/IDSA. When and in whom to initiate HCV therapy. https:// www.hcvguidelines.org/evaluate/when-whom. Last updated September 2017.

7. Martin NK, et al. Hepatitis C virus treatment for prevention among people who inject drugs: modeling treatment scale-up in the age of direct-acting antivirals. Hepatology. 2013;58(5):1598-1609.

8. Federal Bureau of Prisons. Clinical Guidance. Evaluation and Management of Chronic Hepatitis C Virus (HCV) Infection. https:// www.bop.gov/resources/pdfs/012018_hcv_infection.pdf. Published January 2018.

9. AASLD/IDSA. Testing, evaluation, and monitoring of hepatitis C. https://www.hcvguidelines.org/evaluate. Last updated September 2017.

10. Center on Budget and Policy Priorities. Health reform’s Medicaid expansion. https://www.cbpp.org/health-reforms-medicaid-expansion. Last updated 2019.

11. Chidi AP, et al. Economic and public health impacts of policies restricting access to hepatitis C treatment for Medicaid patients.

Value Health. 2016;19(4):326-334.

12. Center for Health Law and Policy Innovation. State of Medicaid access. https://stateofhepc.org/. Last updated November 2018.

Optimizing Community Reentry for Persons With HCV or HIV/HCV Coinfection 1. Centers for Disease Control and Prevention (CDC). Drug overdose deaths. https://www.cdc.gov/drugoverdose/data/statedeaths.html.

Last updated December 2018.

2. Substance Abuse and Mental Health Services Administration (SAMHSA). Opioid overdose prevention toolkit. Last updated 2018. https://store.samhsa.gov/system/files/sma18-4742.pdf 3. Grebely J, Dore GL. Treatment of HCV in persons who inject drugs: treatment as prevention. Clin Liver Dis. 2017;9(4):77-80.

4. Kattakuzhy S, et al. Expansion of treatment for hepatitis C virus infection by task shifting to community-based nonspecialist providers: a nonrandomized clinical trial. Ann Intern Med. 2017;167(5):311-318.

5. Gulati R, et al. Health literacy and liver disease. Clin Liver Dis. 2018;11(2):48-51.

6. Akiyama MJ, et al. Linkage to HCV care and reincarceration following release from New York City jails. J Hepatol. 2018(68 suppl 1):S175-S176.

7. American Association for the Study of Liver Diseases/Infectious Diseases Society of American (AASLD/IDSA). Monitoring patients who are starting HCV treatment, are on treatment, or have completed therapy. https://www.hcvguidelines.org/evaluate/monitoring.

Last updated May 2018.

8. Norton BL, et al. Retention in buprenorphine treatment is associated with improved HCV care outcomes. J Subst Abuse Treat.

2017;75:38-42.

9. Smith-Palmer J, et al. Achieving sustained virologic response in hepatitis C: a systematic review of the clinical, economic and quality of life benefits. BMC Infect Dis. 2015;17:15-19.

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